Safe and reliable processes
Normec supports organisations with independent quality management system certification according to international standards such as ISO 13485 and ISO 9001. Through audits, assessments and practical guidance, we help organisations strengthen their quality management systems and maintain compliance with applicable regulations.
ISO 13485 certification for healthcare
ISO 13485 is the international standard for quality management systems in the medical device industry. It focuses on safety, risk management and demonstrating control over processes throughout the entire lifecycle of medical devices.
Our ISO 13485 certification services include:
- Quality management system audits
- Assessment of processes and documentation
- Support with compliance and regulatory requirements
- Risk management within production and quality processes
- Surveillance audits and recertification
ISO 9001 certification for continual improvement
ISO 9001 helps organisations improve process efficiency, consistency and customer focus. As the world's leading quality management standard, it provides a framework for continual improvement. Normec supports organisations with ISO 9001 certification projects and certification audits.
Our expertise includes:
- Assessment of quality processes and procedures
- Audits of internal control systems
- Monitoring continual improvement
- Demonstrating quality to customers and regulatory authorities
- Strengthening compliance and risk management
With our support, you can:
- Demonstrate the reliability of your processes
- Improve compliance with quality standards
- Be fully prepared for audits and inspections
- Build greater confidence among customers and partners
- Drive continual quality improvement
Future-proof quality management systems
Normec combines specialist expertise in quality management and regulatory requirements with extensive experience across the life sciences and healthcare sectors.
Through independent assessments, audits and certification services, we help organisations develop future-proof quality management systems that continue to comply with international standards such as ISO 13485 and ISO 9001.
Would you like to know more about Quality Management System Certification?
Frequently Asked Questions
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ISO 13485 is the international standard for quality management systems within the medical device industry.
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Certification demonstrates that an organisation's processes meet recognised requirements for quality, safety and regulatory compliance relating to medical devices.
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ISO 9001 is an internationally recognised quality management standard that helps organisations continually improve their processes and performance.
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We support organisations operating in healthcare, pharmaceuticals, biotechnology, medical devices and other life sciences sectors.
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A certification audit assesses whether an organisation complies with the requirements of a specific management system standard.
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Quality management systems help organisations manage their processes in a controlled, safe and efficient manner while supporting continual improvement.
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Yes. We also support organisations with surveillance audits and recertification programmes.